TWI851622B - 包含蛋白質的穩定液體組成物 - Google Patents

包含蛋白質的穩定液體組成物 Download PDF

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Publication number
TWI851622B
TWI851622B TW108141678A TW108141678A TWI851622B TW I851622 B TWI851622 B TW I851622B TW 108141678 A TW108141678 A TW 108141678A TW 108141678 A TW108141678 A TW 108141678A TW I851622 B TWI851622 B TW I851622B
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TW
Taiwan
Prior art keywords
liquid composition
acidic
protein
histidine
hmw
Prior art date
Application number
TW108141678A
Other languages
English (en)
Chinese (zh)
Other versions
TW202033216A (zh
Inventor
鄭榮碩
洪慈慧
朱景熙
李才慜
李憲周
金龍局
Original Assignee
南韓商三星Ｂｉｏｅｐｉｓ股份有限公司
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
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Application filed by 南韓商三星Ｂｉｏｅｐｉｓ股份有限公司 filed Critical 南韓商三星Ｂｉｏｅｐｉｓ股份有限公司
Publication of TW202033216A publication Critical patent/TW202033216A/zh
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Publication of TWI851622B publication Critical patent/TWI851622B/zh

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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00—Medicinal preparations containing antigens or antibodies
    • A61K39/395—Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum
    • A61K39/39533—Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum against materials from animals
    • A61K39/3955—Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum against materials from animals against proteinaceous materials, e.g. enzymes, hormones, lymphokines
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00—Medicinal preparations containing antigens or antibodies
    • A61K39/395—Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum
    • A61K39/39591—Stabilisation, fragmentation
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/08—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
    • A61K47/12—Carboxylic acids; Salts or anhydrides thereof
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/16—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing nitrogen, e.g. nitro-, nitroso-, azo-compounds, nitriles, cyanates
    • A61K47/18—Amines; Amides; Ureas; Quaternary ammonium compounds; Amino acids; Oligopeptides having up to five amino acids
    • A61K47/183—Amino acids, e.g. glycine, EDTA or aspartame
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/22—Heterocyclic compounds, e.g. ascorbic acid, tocopherol or pyrrolidones
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/26—Carbohydrates, e.g. sugar alcohols, amino sugars, nucleic acids, mono-, di- or oligo-saccharides; Derivatives thereof, e.g. polysorbates, sorbitan fatty acid esters or glycyrrhizin
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/0012—Galenical forms characterised by the site of application
    • A61K9/0019—Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/08—Solutions
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K16/00—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies
    • C07K16/18—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans
    • C07K16/28—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants
    • C07K16/2875—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants against the NGF/TNF superfamily, e.g. CD70, CD95L, CD153, CD154
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00—Medicinal preparations containing antigens or antibodies
    • A61K2039/54—Medicinal preparations containing antigens or antibodies characterised by the route of administration
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2317/00—Immunoglobulins specific features
    • C07K2317/90—Immunoglobulins specific features characterized by (pharmaco)kinetic aspects or by stability of the immunoglobulin
    • C07K2317/94—Stability, e.g. half-life, pH, temperature or enzyme-resistance

Landscapes

  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • General Health & Medical Sciences (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Epidemiology (AREA)
  • Animal Behavior & Ethology (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Engineering & Computer Science (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Immunology (AREA)
  • Biochemistry (AREA)
  • Molecular Biology (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Mycology (AREA)
  • Microbiology (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Organic Chemistry (AREA)
  • Genetics & Genomics (AREA)
  • Dermatology (AREA)
  • Biophysics (AREA)
  • Endocrinology (AREA)
  • Medicinal Preparation (AREA)
TW108141678A 2018-11-16 2019-11-15 包含蛋白質的穩定液體組成物 TWI851622B (zh)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
KR10-2018-0141556 2018-11-16
KR20180141556 2018-11-16

Publications (2)

Publication Number Publication Date
TW202033216A TW202033216A (zh) 2020-09-16
TWI851622B true TWI851622B (zh) 2024-08-11

Family

ID=70730554

Family Applications (1)

Application Number Title Priority Date Filing Date
TW108141678A TWI851622B (zh) 2018-11-16 2019-11-15 包含蛋白質的穩定液體組成物

Country Status (9)

Country Link
US (1) US20220008536A1 (ko)
EP (1) EP3881865A4 (ko)
KR (1) KR20210079373A (ko)
CN (1) CN113365658A (ko)
AU (1) AU2019378544A1 (ko)
BR (1) BR112021009548A2 (ko)
CA (1) CA3120190A1 (ko)
TW (1) TWI851622B (ko)
WO (1) WO2020101452A1 (ko)

Families Citing this family (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN114099672B (zh) * 2022-01-28 2022-05-06 嘉和生物药业有限公司 具有增强稳定性的抗rankl人源化单克隆抗体的药物组合物
KR20240163906A (ko) * 2023-05-11 2024-11-19 씨제이제일제당 (주) 포스포리파아제 안정화용 조성물 및 이를 이용한 포스포리파아제 안정화 방법

Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN101217979A (zh) * 2005-06-14 2008-07-09 安姆根有限公司 自缓冲蛋白制剂
WO2018200918A1 (en) * 2017-04-28 2018-11-01 Amgen Inc. Formulations of human anti-rankl antibodies, and methods of using the same

Family Cites Families (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CA2790018C (en) * 2006-12-21 2015-02-03 Amgen Inc. Formulations
AU2009210741A1 (en) * 2008-02-07 2009-08-13 Amgen Inc. Stabilized protein compositions
WO2015134406A1 (en) * 2014-03-03 2015-09-11 La Jolla Biologics, Inc. Stable aqueous recombinant protein formulations
TW201726111A (zh) * 2015-09-30 2017-08-01 持田製藥股份有限公司 含高濃度抗體之液體製劑
CN108686204A (zh) * 2017-04-07 2018-10-23 浙江海正药业股份有限公司 包含组氨酸缓冲体系的英夫利西单抗组合物

Patent Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN101217979A (zh) * 2005-06-14 2008-07-09 安姆根有限公司 自缓冲蛋白制剂
WO2018200918A1 (en) * 2017-04-28 2018-11-01 Amgen Inc. Formulations of human anti-rankl antibodies, and methods of using the same

Also Published As

Publication number Publication date
AU2019378544A1 (en) 2021-06-10
TW202033216A (zh) 2020-09-16
BR112021009548A2 (pt) 2021-08-17
CN113365658A (zh) 2021-09-07
US20220008536A1 (en) 2022-01-13
WO2020101452A1 (ko) 2020-05-22
EP3881865A1 (en) 2021-09-22
CA3120190A1 (en) 2020-05-22
KR20210079373A (ko) 2021-06-29
EP3881865A4 (en) 2022-07-20

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